The information provided here is not intended to provide information to patients and the general public. All rights reserved. Several of these demonstrated magnetic field interactions. All other trademarks are the property of their respective owners. Boston Scientific 2 Agenda I. As a result, readers are cautioned not to place undue reliance on any of our forward-looking statements. Coils, Filters, Stents, and Grafts More. Fortunately, the devices that exhibited po . 1 0 obj << /Creator (Venous Wallstent SSED vers 2 - Microsoft Word) /CreationDate (D:20020508130644Z) /Title (P980033) /Author (Author: ODE) /Producer (Acrobat PDFWriter 5.0 for Windows NT) /Subject (Issue: 11-16-2001) /Keywords (Posted: 05-08-2002) /ModDate (D:20020508134926-03'00') >> endobj 2 0 obj [ /PDF /Text ] endobj 3 0 obj << /Pages 60 0 R /Type /Catalog /Metadata 87 0 R >> endobj 4 0 obj << /Type /Page /Parent 5 0 R /Resources << /Font << /F0 6 0 R /F1 8 0 R /F2 10 0 R /F3 12 0 R >> /ProcSet 2 0 R >> /Contents 14 0 R /Thumb 65 0 R >> endobj 5 0 obj << /Kids [ 4 0 R 16 0 R 21 0 R 27 0 R 30 0 R 36 0 R ] /Count 6 /Type /Pages /Parent 60 0 R >> endobj 6 0 obj << /Type /Font /Subtype /TrueType /Name /F0 /BaseFont /TimesNewRoman /FirstChar 32 /LastChar 255 /Widths [ 250 333 408 500 500 833 778 180 333 333 500 564 250 333 250 278 500 500 500 500 500 500 500 500 500 500 278 278 564 564 564 444 921 722 667 667 722 611 556 722 722 333 389 722 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/Descent -220 /Leading 225 /MaxWidth 1043 /AvgWidth 600 >> endobj 14 0 obj << /Length 15 0 R /Filter /FlateDecode >> stream THE List - MRI Safety The delivery system is of coaxial design with an exterior shaft to protect and constrain the stent prior to deployment. "Following the recent presentation of our nine-month data, the 12-month ORION data continue to show very strong clinical outcomes," said Dr. Clair. 121 0 obj <>stream 1.5,3: Conditional 5 More . We disclaim any intention or obligation to publicly update or revise any forward-looking statements to reflect any change in our expectations or in events, conditions or circumstances on which those expectations may be based, or that may affect the likelihood that actual results will differ from those contained in the forward-looking statements. Note: Boston Scientific is not responsible for the correct use of codes on submitted claims; this informationdoes not constitute reimbursement or legal advice. AccessGUDID - Ascerta Firm (08714729861720)- Ureteral Stent. This site is Exclusively Sponsored by BRACCO, ENTERRA THERAPY, Gastric Electrical Stimulation (GES), Neurostimulation System, Orthopedic Implants, Materials, and Devices, Cerebrospinal Fluid (CSF) Shunt Valves and Accessories, Hemostatic Clips, Other Clips, Fasteners, and Staples. No use of any Abbott trademark, trade name, or trade dress in this site may be made without the prior written authorization of Abbott, except to identify the product or services of the company. Search for arrhythmia, heart failure and structural heart IFUs. Medical Device Recalls, Recalls, Market Withdrawals and Safety Alerts, Boston Scientific Corporation Recalls VICI VENOUS STENT System and VICI RDS VENOUS STENT System for Potential of Stent Migration, VICI VENOUS STENT System (VICI SDS) and VICI RDS VENOUS STENT System, Distribution Dates: September 21, 2018 to April 9, 2021, Health care providers using the VICI VENOUS STENT System and VICI RDS VENOUS STENT System, Patients who have a procedure using the VICI VENOUS STENT System or VICI RDS VENOUS STENT System, Immediately discontinue use of the device, Remove all affected units from inventory and secure them, Complete the company's Verification Form to acknowledge receipt and report products that will be returned, Package affected products for shipping and contact the local Boston Scientific representative to arrange for their return. The prospective, single-arm ORION trial enrolled 125 patients at 28 sites in the United States. AccessGUDID - DEVICE: Epic Vascular (08714729805014) One lot of one catalog number of the Sentinol Nitinol Biliary Stent System may have been packaged in a Sentinol nitinol Vascular outer carton. Follow the checklist instructions within Merlin PCS Programmer. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Due to the use of intense magnetic fields in MRI examinations, implanted medical devices that contain metal may be subject to potential migration and heating within the body. THE List - MRI Safety Proper patient monitoring must be provided during the MRI scan. 59 0 obj <> endobj Orthopedic Implants, Materials, and Devices More. An official website of the United States government, : The MRI parameter settings are selected at the physician's discretion. Many of our pacemakers (leadless and traditional), ICDs, ICMs, CRT-Ds, CRT-Ps, pressure sensors, heart valves, occluders and annuloplasty rings are MR Conditional. 510(K)s with Product Code = FGE and Original Applicant = BOSTON SCIENTIFIC CORP. Metal Expandable Biliary Stents - Food and Drug Administration We recommend that you download and review the most current version any time a patient with an Abbott product needs an MRI. The positive data support the Boston Scientific goal of delivering products designed to reduce the need for reinterventions and help lower overall healthcare costs. To look up your patients system, use the Product Search tool to determine whether your patients device and leads (if applicable) are safe for an MRI. {}(;]xjx$,&\I'esU7;O*G@MI9YO?V6t N=9nq}^I pk2f5RVw>bd.Ms@G7'^,UPX_4~KO$rS8ILEn5WVu >V:RD/L u 9cwM\^$h IOK #>of=eP V}-St:Ur{>J;{n=b^mZ? Alternatively, you can also use the latest MRI Manuals to determine scan parameters. If the stent migrates to the heart, it could cause life-threatening injury. As a result, DFUs for stent systems containing metal usually recommend a waiting period of approximately two months from the time of implantation until an MRI can be performed safely. Instructions for Downloading Viewers and Players, Class 3 Device Recall Sentinol Nitinol Biliary Stent System. Instructions for Downloading Viewers and Players. You can search by product, model number, category or family. The results found that the stent was MRI . Drummond wire (316L SS) orthopedic implant. "The Epic Stent has been very well-received by physicians across the country. Catalog No. (0.89mm) guidewires. Download the MRI Ready Systems Manual or MRI Ready Leadless System Manual for additional details about patient monitoring. Boston Scientific Corporation One Boston Scientific Place Natick, MA 01760-1537 1.888.272.1001 www.BostonScientific.com . It may be a continuous tube or a mesh structure in tubular form and is available in a variety of lengths and diameters. Boston Scientific, www.bostonscientific.com . Be sure to check the lead combination(s) (if applicable) to ensure you select the correct settings. (,OcEh{[%E#Xl@::9(k]xv# q#fs+[Jb{-$r;EB9 pdRkEdq^(PFG3|'ae1wsv4N5:YBswO[kQC9U0EJ[Tkd/*4s3_SN}W~jj,SPuT-9 )44ZtGtWAO@Fo aP3lqS-P*)v"rj5QEWL!zg8KbORyvm?B'tZ&3D#>7"7Q8&a*$"xmVTeV [@[@.o)BpiyHpV1FIh\w|wD!2N^# U#gb a]qkz,'@Ri3 Safety Topic / Subject ALIMAXX-B Uncovered Biliary Stent 10-mm x 80-mm . epic vascular self-expanding stent system: Boston Scientific Corp. P110035 S045: 04/03/2018: memorygel silicone gel-filled breast implants: MENTOR CORP. P030053 S045: 01/30/2018: reflection ceramic acetabular hip system: Smith & Nephew, Inc. P030022 S045: Platinum Chromium Coronary Stent System (Monorail) Device Procode: Applicant's Name and Address: NIQ . Conditional 6 More. @Bd!$7@"rAOgx May be removed prior to MRI and replaced after the MRI exam. They appreciate the radial force of the stent, which helps allow the artery to stay open, and the flexibility in its design, which helps in deliverability. Magnetic Resonance Imaging (MRI) Safety for Boston Scientific Peripheral Products PDF, 272.0 KB. Boston Scientific, www.bostonscientific.com, Neuroform Atlas Stent Non-clinical testing and analysis have demonstrated that the Neuroform Atlas Stent is MR Conditional alone, or when overlapped with a second stent, and adjacent to a Stryker Neur, AAA Endograft Ovation Ovation Abdominal Stent Graft System TriVascular2, Inc. Santa Rosa, CA, Abre StentMedtronic, Inc., www.Medtronic.com/MRI, Absolute .035 Biliary Self-Expanding StentAbbott Vascular, www.abbottvascular.com, ABSOLUTE 0.35 Biliary Self Expanding Stent System Guidant http://www.guidant.com/ifu/, Absolute Biliary StentAbbott Vascularwww.abbottvascular.com, Absolute Pro .035 Biliary Self-Expanding StentAbbott Vascular, www.abbottvascular.com, Absolute Pro Peripheral Stent Abbott Vascular www.Abbott.com, Absolute Pro Stent Nickel titanium with nickel titanium platinum markers 8-mm x 120-mm Single version Abbott Vascular Santa Clara, CA, Absolute Pro Stent Nickel titanium with nickel titanium platinum markers 8-mm x 348-mm three overlapped version Abbott Vascular Santa Clara, CA, ABSOLUTE Biliary Self-Expanding Stent System Nitinol coils, filters, stents Guidant Endovascular Solutions Santa Clara, CA, Absorb Bioresorbable Vascular Scaffold (BVS) SystemAbbott Vascular, www.abbottvascular.com, Absorb GT1 Bioresorbable Vascular Scaffold (BVS) SystemAbbott Vascular,www.abbottvascular.com, Acculink Carotid StentAbbott Vascularwww.abbottvascular.com, ACCULINK Carotid StentGuidanthttp://www.guidant.com/ifu/, ACS MULTI-LINK Coronary StentAbbott Vascularwww.abbottvascular.com, ACS MULTI-LINK DUET Coronary StentAbbott Vascularwww.abbottvascular.com. Use this database for coronary intervention, peripheral intervention and valve repair products. of Abbott Medical Japan GK. NATICK, Mass., Oct. 23, 2012 /PRNewswire/ --Boston Scientific Corporation (NYSE: BSX) reports twelve-month clinical endpoint data from the ORION trial, which demonstrated robust safety and effectiveness outcomes for the Epic Self-Expanding Nitinol Stent System in patients with obstructed iliac arteries. Download the MRI Ready Systems Manual or MRI Ready Leadless System Manual to review a list of adverse conditions and effects. Boston Scientific Corporation Recalls VICI VENOUS STENT System and VICI 0 Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. Company Name: BOSTON SCIENTIFIC CORPORATION Primary DI Number: 08714729802976 Issuing Agency: GS1 Commercial Distribution End Date: Device Count: 1 Labeler D-U-N-S Number*: 021717889 * Terms of Use Device Description: Ureteral Stent CLOSE Device Characteristics Device Record Status Alternative and Additional Identifiers Customer Contact [?] Abbotts MRI-Ready High Voltage Device Setup for Gallant and Entrant ICD and CRT-Ds (11:45). MR imaging provides excellent spatial . "The Epic Stent is a novel stent platform designed to offer both acute and clinical advantages over older-generation stent systems. Upon approval, the Epic Stent along with the market-leading Express LD balloon-expandable iliac stent, would enable Boston Scientific to offer a complete line of advanced iliac solutions for physicians and patients." The Epic Stent should not migrate in this MRI environment. Dont scan the patient if any adverse conditions are present. For more information, please visit: www.bostonscientific.com. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. AccessGUDID - DEVICE: Ascerta (08714729802976) The Boston Scientific Epic Stent Continues to Demonstrate Positive The C-code used for this product is C1876, Stent, non-coated/non-covered with delivery system. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. The Sentinol Nitinol Stent System is comprised of two components: the implantable endoprosthesis and the stent delivery system. This scientific statement is intended to summarize and clarify issues regarding the safety of MR imaging in patients with cardiovascular devices. The revised Express2 bare-metal stent DFU will be available shortly. The .gov means its official.Federal government websites often end in .gov or .mil. Device Size Text, specify: 75 cm Effective Length, Device Size Text, specify: 40 mm Stent Length, Device Size Text, specify: 10 mm Stent Diameter. On April 12, 2021, Boston Scientific Corporation sent an Urgent Medical Device Recall Notification to customers asking them to: Customers with questions should contact their Boston Scientific sales representative. About Boston ScientificBoston Scientific is a worldwide developer, manufacturer and marketer of medical devices that are used in a broad range of interventional medical specialties. It is required to program the device to MRI Settings as part of the MRI scan workflow. CAUTION: These products are intended for use by or under the direction of a physician. This stent has not been evaluated to determine if it is MR Conditional beyond these conditions. No deaths have been reported.
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